Hot pharmaceutical raw material Ciprofloxacin Hcl
1.CAS No:86393-32-0
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| Ciprofloxacin Hydrochloride |
| [Chemical Name] | |||
| 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid·Hydrochloride·Monohydrate | |||
| [Structure Formula] | |||
| [Molecular Formula] | |||
| C17H18FN3O3·HCl·H2O | |||
| [Molecular Weight] | |||
| 385.81 | |||
| [Specification] | |||
| USP32, EP6, BP2010 | |||
| [Uses] | |||
| It is a broad-spectrum antibiotic of high efficacy |
ANALYSIS AS PER USP 34
|
Items of Test |
Standard |
Result of Test |
|
Appearance |
White or light yellow crystalline powder |
conform |
|
Identification (a) IR
(b) TLC
(c) the reaction of chloride |
IR spectrum of sample corresponds to that of reference standard. The intensity and RF value of the principal band obtained from the test solution corresponds to that obtained from the standard solution. A solution of IIresponds to the tests of chloride |
Conform
Conform
Conform |
|
Related substances HPLC |
Chromatographic purity ≤ 0.2% Ciprofloxacin ethylenediamine analog ≤ 0.2% Unspecified impurity ≤ 0.50% Total impurities ≤ 0.5% |
0.15% <0.11% 0.40% |
|
Ph |
3.0-4.5 |
3.7 |
|
Heavy metals |
≤20ppm |
<20ppm |
|
Fluoroquinolonic acid |
≤0.2% |
Conform |
|
Sulphated ash |
≤0.04% |
<0.04% |
|
Water |
4.7%-6.7% |
5.90% |
|
Residue of ignition |
≤0.1% |
0.05% |
|
Residual solvent |
ethanol ≤ 5000ppm Isoamyl alcohol≤ 4000ppm |
560ppm Not found |
|
Assay (HPLC) |
98.0%-102% |
99.8% |
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